MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 60 CM; SCS LEAD

Model Number 3156

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Increased Sensitivity (2065); Seroma (2069)

Event Date 03/13/2015

Event Type  Injury  

Event Description

Device 1 of 4 reference mfr.Report# 1627487-2015-20194 reference mfr.Report# 1627487-2015-20195 reference mfr.Report# 1627487-2015-20196 further follow up identified the patient's seroma is "better".The date of implant for the devices was received and is listed in.

Manufacturer Narrative

The patient received two leads with same lot number (3218983).This lot number was reported in device 2.Mfr.Report # 27487-2015-20196 was inadvertently reported as device 4.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 1 of 4.Reference mfr.Report# 1627487-2015-20194.Reference mfr.Report# 1627487-2015-20195.Reference mfr.Report# 1627487-2015-20196.It was reported the patient ((b)(4)) underwent revision on(b)(6) 2015 to connect leads to the ipg which were left implanted during previous surgical intervention ( reference mfr.Report# 1627487-2015-21011).However, the physician observed the patient's lead entry site was red and inflamed with the presence of seroma.As a result, the physician explanted the leads and a culture was taken.The patient was implanted with four leads of model 3156.The lot no for the fourth lead is unknown.The implant date for all the devices is unknown.

Manufacturer Narrative

(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Manufacturer Narrative

(b)(4).The reported event for redness and seroma at the lead site could not be confirmed and analyzed through product testing alone.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 1 of 4.Reference mfr.Report# 1627487-2015-20194.Reference mfr.Report# 1627487-2015-20195.Reference mfr.Report# 1627487-2015-20196.The patient received two leads (device 2 and device 4) from the same lot number (3218983).

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4636298
• MDR Text Key: 5670278
• Report Number: 1627487-2015-20193
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 3156
• Device Lot Number: 3158105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other